Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Condom
510(k) Number K082529
Device Name ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
Applicant
ALATECH HEALTHCARE, LLC.
1600 STATE DOCKS RD.
EUFAULA,  AL  36027
Applicant Contact NEIL ANDERSON
Correspondent
ALATECH HEALTHCARE, LLC.
1600 STATE DOCKS RD.
EUFAULA,  AL  36027
Correspondent Contact NEIL ANDERSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/02/2008
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-